JS107 vs Investigator's Choice as Second-line or Later Therapy for Advanced CLDN18.2-Positive Gastricor GEJ Adenocarcinoma.
Trial Parameters
Brief Summary
This is a multicenter, randomized, controlled, open-label, Phase III study, designed to evaluate the efficacy and safety of JS107 versus investigator-selected therapy in the second-line or later treatment of patients with advanced gastric or gastroesophageal junction adenocarcinoma positive for CLDN18.2. The study population consists of patients with CLDN18.2-positive, HER2-negative, locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma who have received at least one prior line of systemic therapy. The primary endpoints of the study are BICR-assessed progression-free survival and overall survival. Number of subjects and allocation:This study plans to enroll approximately 560 subjects, who will be randomized in a 1:1 ratio to receive either JS107 (experimental group) or investigator-selected therapy (control group).
Eligibility Criteria
Inclusion Criteria: 1. Voluntarily participate in this study, have ICF signed after sufficient informed consent, and have good compliance. 2. Age ≥ 18 years, male or female. 3. ECOG PS 0 or 1. 4. Expected survival period≥ 3 months. 5. Patients with HER2 negative G/GEJ adenocarcinoma confirmed by histology/cytology. 6. Patients who have received at least one prior line of systemic treatments and developed PD, and the previous treatment must include fluorouracil and platinum. 7. Fresh or archival tumor tissue (blocks of formalin-fixed, paraffin-embedded \[FFPE\] tissue or unstained FFPE tumor tissue sections) must be available and comfirmed CLDN18.2 positivity by for central laboratory through immunohistochemistry (IHC) before randomization. 8. Having ≥ 1 measurable lesion according to RECIST v1.1 (per investigator assessment). 9. Any AEs and/or complications caused by previous therapies including surgery or radiotherapy have been adequately resolved to Grade 0 or 1 (per NCI-CTCAE v5.0 c